Combining health and social protection measures to reach the ultra ...

InnovationThe changes in international IP legislative frameworksthrough treaties are rapidly changing national legislation. Andthese changes are profoundly affecting how healthinnovations reach the poor and how public and privateresearch and development institutions pursue their work. IPrights are sometimes viewed as barriers to innovations inhealth and other areas. In some circumstances, they are. Butthis paper argues that overall it is not intellectual property, perse, that obstructs access, but rather how intellectual propertyis used and managed. What matters most is how creativelypublic sector institutions integrate IP considerations into theiroverall business models and approaches. Seen in this light,the legislative framework provides a solid foundation for astable, predictable judiciary, which also allows the publicsector to use a national IP system as a tool to achieve itsgoals. A stable IP system empowers the public sector toimagine, anticipate, and act.The policy choicesDetermining how institutions can adopt and adapt theadvantages conferred by TRIPS and other legislativeinitiatives is crucial. For example, government policies arehugely important for establishing to what extent public sectorinstitutions will practise IP management. In the UnitedStates, no other policy choice had a more significant impactthan the Bayh-Dole Act and other legislative and policydecisions in the early 1980s. They created conditions thatspurred investment in biotechnology R&D, leading tonumerous health innovations. But above all, these policychoices greatly affected how universities and public sectorresearch institutions manage intellectual property and theirrelationship with the private sector.Although the circumstances of countries vary enormously,the following set of questions are nearly universally relevant:when should public sector R&D centres or universities seekpatent protection for their inventions? What informationrelated to research should they keep confidential, if any?Under what circumstances should the public sector grantaccess (in other words license) their intellectual property? Andunder what terms? And to whom? These questions do nothave simple answers. This is largely because the answers willdepend on the context in which they emerge. Even within thesame institution, the answers may be diametrically opposedfor different types of inventions. Given these complexities,what should be the government’s role in the area of policy?First of all, establishing an open, transparent governmentpolicy for the ownership of publicly funded research is animportant foundation for building sound institutional IPmanagement. Institutional leaders have little latitude whenthe underlying rules are opaque or not spelled out.Second, the policy rationale for technology transfer inpublic sector institutions should not be based on anticipatedrevenue flows; instead, long-term national, social, andeconomic objectives should structure policy decisions – withpublic benefit as the key factor. Indeed, since governmentfunds much research at national R&D and academicinstitutions, it has the prerogative to mandate certainconditions for the benefit of these institutions’ publicIn the United States, no other policy choice had a moresignificant impact than the Bayh-Dole Act and otherlegislative and policy decisions in the early 1980smissions. Policy-makers have a lot of latitude when it comesto ensuring that investment in research is returned as a publicbenefit. They could certainly require, for example, thatproducts developed and marketed commercially from publiclyfunded research have some provision for delivery to the poor.Third, governments can also strengthen the courts andrecognize their important role in balancing conflicting IPpolicies. Such efforts will provide useful guidance withregards to business, technology, and science planning andstrategy. Not every dispute, however, should be resolved incourt. For public research and product development ingeneral, and for equitable access and meeting the needs ofthe poor in particular, governments have tremendousopportunities to promote policies that foster alternativedispute resolution procedures 4 . Such approaches are oftenpreferable for settling differences between parties. Courtaction is often stymied because of cost, length of procedure,legal uncertainty, a decision-maker’s lack of expertise,conflicts between confidentiality and publicity, the difficulty ofseeking action in foreign jurisdictions, and the negativeimpact on existing business relationships. Arbitration is anattractive option for all of these reasons, and while it is aprivate mechanism, it is not altogether free from regulation bynational laws. Governments and public institutions can helpmake arbitration or mediation procedures accessible andavailable by identifying and supporting neutral institutionsthat can provide cost-efficient, timely dispute resolutionservices. Such approaches would also take much of thenegative public perception out of IP rights, especially fromlegal disputes that can deter increased private participation inmeeting the needs of the poor.Finally, it should be recognized that Product-DevelopmentPartnerships (PDPs) allow the private sector to invest andapply its expertise to address the needs of the poor. Manysuch PDPs are now driving the drug development pipeline inneglected disease R&D. A pioneering new institutionalstructure, PDPs will become increasingly prevalent indeveloping countries and contribute to the development ofproducts in less viable markets. National governments havetremendous opportunities to promote policies and capacitiesthat facilitate these innovative partnerships, especially insuch areas as effective clinical trials and ethical reviewcapacities, appropriate regulatory bodies for clinical researchand product approval, and national and institutional IPpolicies that stimulate health and agricultural R&D.Institutional strategiesWhatever the impact of TRIPS and of strengthened patentregimes, institutional IP management capacities will need tobe strengthened so that the legislative and policy changes canGlobal Forum Update on Research for Health Volume 4 ✜ 085